Search Results (5)

This paper presents a new risk assessment methodology called the Integrated Risk Framework (IRF) through the application of Ishikawa diagrams combined with the enhanced Hazard Analysis and Critical Control Point (HACCP) system. This risk investigation technique aims to ensure a significantly higher level of quality, safety, and sustainability in food products by using improved classical methods with strong intercorrelation capabilities. The methodology proposes expanding the typology of basic physical, chemical, and biological risks outlined by the ISO 22000 Food Safety Management System standard, adding other auxiliary risks such as allergens, fraud/sabotage, Kosher/Halal compliance, Rapid Alert System for Food and Feed notification, or additional specific risks such as irradiation, radioactivity, genetically modified organisms, polycyclic aromatic hydrocarbons, African swine fever, peste of small ruminants, etc. depending on the specific technological process or ingredients. Simultaneously, it identifies causes for each operation in the technological flow based on the 5M diagram: Man, Method, Material, Machine, and Environment. For each identified risk and cause, its impact was determined according to its severity and likelihood of occurrence. The final effect is defined as the risk class, calculated as the arithmetic mean of the impact derived at each process stage based on the identified risks and causes. Within the study, the methodology was applied to the spring water bottling process. This provided a new perspective on analyzing the risk factors during the bottling operations by concurrently using Ishikawa diagrams and HACCP principles throughout the product’s technological flow. The results of the study can form new methodologies aimed at enhancing sustainable food safety management strategy. In risk assessment using these two tools, the possibility of cumulative or synergistic effects is considered, resulting in better control of all factors that may affect the manufacturing process. This new perspective on studying the dynamics of risk factor analysis through the simultaneous use of the fishbone diagram and the classical HACCP system can be extrapolated and applied to any manufacturing process in the food industry and beyond. Full article

Furniture production is a specific industrial sector with a high human labor demand, a wide range of materials processed, and short production runs caused by high customization of end products. The difficulty of measuring the aesthetic requirements of customers is also specific to furniture. This review of academic papers identifies and explains effective quality management strategies in furniture production. The reviewed literature highlights a range of quality management methodologies, including concurrent engineering (CE), total quality management (TQM), lean manufacturing, lean six sigma, and kaizen. These strategies encompass a variety of pro-quality tools, such as 5S, statistical process control (SPC), quality function deployment (QFD), and failure mode and effects analysis (FMEA). The strengths of these quality management strategies lie in their ability to enhance efficiency, reduce waste, increase product diversity, and improve product quality. However, the weaknesses concern implementation challenges and the need for culture change within organizations. Successful quality management in furniture production requires tailoring strategies to the specific context of the furniture production industry. Additionally, the importance of sustainability in the furniture industry is emphasized, which entails incorporating circular economy principles and resource-efficient practices. The most important finding from the literature analysis is that early detection and correction of poor quality yields the most beneficial outcomes for the manufacturer. Therefore, it is essential to strengthen the rigor of quality testing and analysis during the early stages of product development. Consequently, a deep understanding of consumer perspectives on required furniture quality is crucial. The review identified two research gaps: (1) the impact of unnecessary product over-quality on the efficiency of furniture production and (2) the influence of replacing CAD drawings with a model-based definition (MBD) format on quality management in furniture production. Full article

The objective of the present work was to develop PTH (1-34)-loaded stealth nanoliposomes (PTH-LPs) by employing the use of the Quality by Design (QbD) approach. Risk identification was carried out using the Ishikawa fishbone diagram. PTH-LPs were optimized using Box Behnken Design, a type of response surface methodology to examine the effect of independent variables on dependent variables such as particle size and percentage entrapment efficiency (%EE). Design space was generated for PTH-LPs to reduce interbatch variability during the formulation development process. Furthermore, a cytotoxicity assay, cell proliferation assay, calcium calorimetric assay, mineralized nodule formation, and cellular uptake assay were carried out on MG-63 osteoblast-like cells. The results obtained from these procedures demonstrated that lipid concentration had a significant positive impact on particle size and %EE, whereas cholesterol concentration showed a reduction in %EE. The particle size and %EE of optimized formulation were found to be 147.76 ± 2.14 nm and 69.18 ± 3.62%, respectively. Optimized PTH-LPs showed the sustained release profile of the drug. In vitro cell evaluation studies showed PTH-LPs have good biocompatibility with MG-63 cells. The cell proliferation study revealed that PTH-LPs induced osteoblast differentiation which improved the formation of mineralized nodules in MG-63 cells. The outcome of the present study conclusively demonstrated the potential of the QbD concept to build quality in PTH-LPs with improved osteoanabolic therapy in osteoporosis. Full article

As regulatory and technical landscapes for pharmaceutical formulation development are rapidly evolving, a risk-management approach using multivariate analysis is highly essential for designing a product with requisite critical quality attributes (CQA). Efinaconazole, a newly approved poorly water-soluble antifungal triazole drug has poor permeability. Spanlastics, new-generation surfactant nanovesicles, being fluidic, help improve the permeability of drugs. Therefore, we optimized efinaconazole spanlastics using the concepts of Formulation-by-Design (FbD) and explored the feasibility of transungual delivery for the management of onychomycosis. Using the Ishikawa fishbone diagram, the risk factors that may have an impact on the CQA of efinaconazole spanlastic vesicles were identified. Application of the Plackett–Burman experimental design facilitated the screening of eight different formulation and process parameters influencing particle size, transmittance, relative deformability, zeta potential, entrapment efficiency, and dissolution efficiency. With the help of Pareto charts, the three most significant factors were identified, viz., vesicle builder (Span), edge activator (Tween), and mixing time. The levels of these three critical variables were optimized by FbD to reduce the particle size and maximize the transparency, relative deformability, encapsulation efficiency, and dissolution efficiency of efinaconazole spanlastic nanovesicles. Bayesian and Lenth’s analysis and mathematical modeling of the experimental data helped to quantify the critical formulation attributes required for getting the formulation with optimum quality features. The optimized efinaconazole-loaded spanlastic vesicles had a particle size of 197 nm, transparency of 91%, relative deformability of 12.5 min, and dissolution efficiency of 81.23%. The spanlastic formulation was incorporated into a gel and explored ex vivo for transungual delivery. This explorative study provides an example of the application of principles of risk management, statistical multivariate analysis, and the FbD approach in developing efinaconazole spanlastic nanovesicles. Full article

Low-cost carriers (LCCs) have been growing by 11.4% in revenue passenger kilometers over 2017 and changed the airline industry radically. It drove down prices in the industry. Southwest Airlines (USA) designed the LCC blueprint model, and Ryanair copied it within Europe, followed by other airlines. This research aims to fulfill the gap in contemporary research upon LCC successfulness in Europe by a description of the current situation within Europe (2018 and January 2019) and the development issues it faced, which are mapped by the Ishikawa fishbone diagram. Furthermore, to rank the airlines on strength and vulnerability, The Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) methodology was used for meeting LCC characteristics and airline success. By comparison of meeting the LCC characteristics and the rank of the successfulness, the results of the TOPSIS analysis showed that the airlines meeting the most LCCs characteristics are seemingly less vulnerable to the development issues that airlines are facing, as Wizz Air and Ryanair are meeting most characteristics and are the most successful. Concluded is that airlines meeting the most LCC characteristics are the least vulnerable to current issues. However, major disruptions can still form an issue and limit growth. This research can be useful for comparing and positioning airlines in the market, based on issues and operational choices. Full article